EBB gives clinical trial participants meaningful, plain-language access to their own study data, generating personalised plain-language trial summaries, delivered securely at study close. Regulators are beginning to expect this from sponsors. Patient advocacy groups are demanding it. Evidence shows that data return improves retention, recruitment for future studies, and builds long-term trust in clinical research.
EBB makes doing the right thing easy.
Clinical trial participants contribute months or years of their lives, their health data, and their trust to research that benefits millions. Yet when a study ends, most receive no meaningful information about their own results.
Regulatory pressure is increasing. ICH E6(R3) and evolving FDA guidance are pushing sponsors toward participant data return as a standard of care. Patient advocacy groups are demanding it. Evidence shows that data return improves retention, recruitment for future studies, and builds long-term trust in clinical research.
EBB makes doing the right thing easy.
TransCelerate BioPharma's Individual Participant Data Return (iPDR) initiative, completed in August 2025, produced a four-part resource package to help sponsors operationalise data return: a socialization presentation, a considerations guide, a customisable implementation template, and a webinar series. The initiative acknowledges that while participant demand is clear, the frequency, timing, and type of data returned today is varied and not widespread.TransCelerate BioPharma, Participant Data Return Initiative, transceleratebiopharmainc.com, August 2025.
The MRCT Center at Brigham and Women's Hospital and Harvard has identified data return as consistently desired and often expected by research participants, publishing guidance and case studies since 2017 to support sponsors in implementing compliant return pathways.MRCT Center, Return of Individual Results initiative, mrctcenter.org.
Participants rarely learn what happened in the study they helped run. Exit interviews show this is one of the most common sources of disappointment.
ICH E6(R3), the FDA's patient-focused drug development guidance, and GDPR Article 20 all point in the same direction: participants have a right to their data.
Studies that return data to participants report higher completion rates and significantly greater willingness to join future trials. Data return is not just ethical: it is strategic.
Sponsors or CROs upload SDTM-structured data to the EBB platform.
For each participant, EBB produces a plain-language, branded PDF report. Clinical values are shown alongside reference ranges and plain-English explanations. Charts, tables, and quality of life scores are included where data permits. No two reports are identical.
Reports are distributed to the investigative site for onward sharing, or sent directly to participants via secure email with a single click. Delivery is logged in a tamper-evident, 21 CFR Part 11 compliant audit trail.
Participant data is never stored at the application layer: it passes through, is used to generate the report, and is not retained. This means a simpler compliance footprint for sponsors and stronger privacy guarantees for participants.
As regulatory expectations evolve, returning data to participants is moving from best practice to standard requirement. EBB gives your team a structured, auditable, and repeatable process, without building custom tooling or diverting valuable resource.
Whatever type of study you are running across multiple countries and sites, EBB scales to your participant count and adapts to your study design and local requirements.
TransCelerate's iPDR Considerations Guide advises sponsors on how to build a business case for data return, identify operational impacts, and determine what data to return and to whom. EBB is built to align directly with this framework, accepting standard SDTM domains and generating reports that meet the TransCelerate template's content recommendations.TransCelerate BioPharma, Individual Participant Data Return Package, clinicalleader.com, August 2024.
ICH E6(R3), effective from May 2025, reinforces the principle of participant-centred research and places greater emphasis on transparency, quality by design, and the rights of participants. EBB's audit log is designed to meet 21 CFR Part 11 and ICH E6(R3) requirements as standard.ICH E6(R3) Good Clinical Practice Guideline, 2025.
EBB was built with participants in mind. Every report is written in plain language, not clinical notation. Values are explained and put into context for individuals, charts are labelled, and the language assumes no medical background or advanced health literacy.
For patient advocacy organisations, EBB offers a concrete way to push for participant data return as a standard across the trials your community participates in. We work with advocacy groups to understand what participants most want to see in their reports, and we build that in.
The MRCT Center's return of individual results framework, which informed both Pfizer's Clinical Trial Alumni Programme and TransCelerate's iPDR Package, identifies plain-language communication and contextual explanation as essential elements of any compliant data return. EBB reports are designed to these standards.MRCT Center, Return of Individual Research Results Guidance and Toolkit, Version 1.2, 2022.
Clinical values like SYSBP and LBORRES are translated into 'Your systolic blood pressure' and 'Your result'. Reference ranges, plain-English flags, and contextual notes are included throughout.
Reports include a personal summary, visit-by-visit charts, quality of life scores compared to age-matched population norms, a side effects summary, and a clear next steps section.
We are working with a small group of sponsors, CROs, and patient advocacy organisations ahead of our wider launch. If you would like to follow our progress, receive our articles, or explore whether EBB is right for your next study, leave your details below.